Senior Manager of Manufacturing Science & Technology (MSAT)

Organogenesis, Inc.•Smithfield, RI

46d•Onsite

About The Position

This position is responsible for managing and supporting manufacturing processes throughout their lifecycle, from development to validation and throughout commercial operations. The candidate will lead a team focused on driving continuous improvement, embedding best practices, and enhancing manufacturing efficiency and cost-effectiveness through robust technology transfer, validation, and lifecycle management. The role will be accountable for the direct supervision of scientific staff and strong collaboration with stakeholders both within and outside the company. They must apply scientific and engineering principles to design, optimize, and scale manufacturing processes, ensure seamless technology transfer, and resolve challenges across the product lifecycle. The Senior Manager, Manufacturing Science & Technology (MSAT) will report to the Director, Manufacturing Science & Technology (MSAT). This position is an on-site position primarily at our Smithfield, Rhode Island facility. Initial training will be done at our Canton, MA facility and travel between sites will be required.

Requirements

M.S. or higher in Biochemistry, Biotechnology, Chemical Engineering, or related field with strong understanding of biologics, human cell and tissue products, and/or medical devices (510k/PMA)
5+ years of biotechnology or pharmaceutical industrial experience in a CMC/cGMP environment required
3+ years of management experience required
Strong analytical and problem-solving skills, with a data-driven approach to decision making
Highly skilled communicator, both written and verbal, adept at crafting clear messages and driving alignment with audiences at every level of the organization
Proven ability to optimize resources, balance competing business priorities, and consistently deliver results under tight deadlines
Strong track record in process development, scale up, and technology transfer of cell-based therapeutics
Expertise in leading complex projects and spearheading continuous improvement initiatives
Familiar with the principles of design control

Responsibilities

Work cross-functionally with manufacturing, quality, supply chain, project management, and external partners to ensure business continuity and solve complex technical problems that may arise in production
Deliver technical expertise by evaluating current processes, identifying improvement opportunities, and implementing innovative strategies to boost efficiency and reduce costs
Support the transfer, scale-up, and validation of manufacturing processes, ensuring compliance with regulatory standards
Generate quality control, manufacturing, and design control documentation; participate in the preparation of CMC sections of regulatory submissions
Partner with project teams to prepare business cases, evaluate risks, and produce validation documentation.
Cultivate talent by inspiring innovation and operational excellence while nurturing a culture of continuous learning and growth
Manage budget and resources effectively to meet departmental and organizational goals

Benefits

401k -- generous employer match with immediate vesting and financial planning resources
Comprehensive Medical, Dental and Vision coverage options effective on day one of employment
Flexible Spending Account (medical expenses or dependent care expenses) or Health Savings Account
Company paid insurances including Short Term, Long Term and Life insurances as well as voluntary options
Paid maternity leave and parental leave for all new parents
Adoption benefits
Education Assistance Policy - up to $5,000 per year for all employees
Wellness Program including free trainings on mental health, mindfulness, stress reduction, on-site flu shots and more
Employee Assistance Program
Generous paid time off including vacation, floating holidays, sick days, and company holidays
Free parking including an electric charging station (Canton and La Jolla)
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